New Indications Sample Clauses
The "New Indications" clause defines how the parties will handle the development, approval, and commercialization of additional uses for a product beyond its original approved indication. Typically, this clause outlines the process for proposing, evaluating, and pursuing new therapeutic indications, including responsibilities for regulatory submissions and allocation of costs or revenues related to these new uses. Its core function is to ensure that both parties have a clear framework for expanding the product's market potential while managing rights and obligations related to future opportunities.
New Indications. 7.6.1 In the event that VIDARA receives approval in the TERRITORY to commercially sell PRODUCT for indications other than Chronic Granulomatous Disease and severe, malignant Osteopetrosis, and provided that VIDARA has the right to grant a license to BII in the BI *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. TERRITORY to make, use and sell PRODUCT for such additional indications (a “NEW INDICATIONS LICENSE”), VIDARA shall provide BII written notice thereof.
7.6.2 BII shall notify VIDARA in writing within thirty (30) days of VIDARA’s notice (the “NOTIFICATION PERIOD”) whether BII desires to obtain a NEW INDICATIONS LICENSE. If VIDARA does not receive written notice from BII during the NOTIFICATION PERIOD that BII desires to obtain a NEW INDICATIONS LICENSE, then VIDARA shall have no further obligations under this Section 7.6. If VIDARA does receive written notice from BII that BII desires to obtain a NEW INDICATIONS LICENSE, then BII and VIDARA shall engage in good faith negotiations for sixty (60) business days thereafter regarding the reasonable commercial terms upon which VIDARA would be willing to grant such a license. If at the end of such sixty (60) business day period, BII and VIDARA have not entered into a written agreement under which VIDARA grants a NEW INDICATIONS LICENSE to BII, then VIDARA shall have no further obligation under this Section 7.6.
New Indications. If SPI develops any New Indication(s) for the Products in the Initial Territory, Takeda shall be given the right of first refusal to obtain a license to develop and commercialize the Products for such New Indication(s) in the Initial Territory. SPI shall provide Takeda with notice of any such New Indication(s) once SPI enters into a proof of concept studies or Phase II studies for a New Indication(s) together with all such material information with regard to such New Indication(s) as enables Takeda to evaluate the New Indication(s) and its potential marketability, and if Takeda desires to obtain a license to the New Indication(s) stated in such notice for the Initial Territory pursuant to a separate written license agreement, the Parties shall then negotiate in good faith for a period of [**] after Takeda’s receipt of such notice. If basic terms and conditions of such license agreement have not been agreed upon by the Parties within the foregoing period, SPI shall be entitled to develop and commercialize the Product for such New Indication(s), and Takeda shall have no further rights with respect to such New Indication(s).
New Indications. Provided that: (i) Voyager is not in default of any material term of this Agreement, (ii) DURECT is reasonably satisfied that Voyager has the resources to develop such products and (iii) Voyager and DURECT have agreed to provisions that ensure the diligent Exploitation of such products, DURECT shall agree to grant to Voyager a license under the SBS Technology and/or the SBS Improvements to Exploit a biodegradable polymeric implant (single, solid, preformed macroscopic device) for the treatment of cancers in humans, which cancers are to be specified and mutually agreed to by the parties and based upon experimental data that supports use in such cancers, that utilizes the SBS Technology or the SBS Improvement and contains the Active Agent on the same terms as applicable to the Product under the Agreement.
13. Section 8.4 shall be replaced in its entirety to read as follows:
New Indications. 7.1 Within:
7.1.1 ninety (90) days of the Effective Date the Parties shall, through the medium of the JSC, meet to discuss the possibility of adding following Indications to the Development Plan: *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(b) and
7.1.2 one hundred and eighty (180) days of the Effective Date the Parties shall decide whether to add the first of such indications to the Development Plan, in which case such indication shall become a Principal Indication. The Parties shall then agree the development plan for this Indication and appropriate milestones for this Indication, which development plan shall be incorporated into the Development Plan and which milestones for this indication shall be incorporated into Clause 11 of this Agreement and the other provisions of this Agreement shall apply to such indication as if it had always been a Principal Indication.
7.2 Subject to Clause 7.1, if at any time after the Effective Date a Party comes to the opinion that Development of Product should occur for a New Indication it shall notify that opinion in writing to the other Party identifying the New Indication in question for discussion. Such a proposed New Indication may be the treatment of any illness, pathology or disease condition, recognised as a distinct indication by any Regulatory Authority. In its submission, the suggesting Party shall define the target condition and identify the potential target patient population and market opportunity. Upon receipt of such notice the Parties shall discuss, through the medium of the JSC, the New Indication and the necessary changes to the Lifecycle Management Plan and GW Pharma will conduct Clinical Trials of Product of the New Indication until completion of Phase IIa Clinical Trials at its own cost and expense. Following completion of Phase IIa Clinical Trials for such New Indication by GW Pharma, GW Pharma will promptly compile a data package, in a form set by the JSC, setting out the results of such clinical trials including all Phase IIa clinical data and the Final Report therefor (“Phase IIa Data Package”) and present it to Almirall at the next to occur meeting of the JSC. Almirall shall then review the Phase IIa Data Package and undertake its own *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. decision-making process. At the meetin...
New Indications. With respect to development of any New Indication that the Parties do not agree to develop jointly pursuant to Article 4.5, Organon shall have the right to pursue the development of such New Indication at its sole expense; provided, however, that (i) Organon's development of any such New Indication would not, based on the best available scientific evidence, be reasonably likely to have a materially adverse effect on the Product then being Co-Promoted by the Parties; and (ii) the Product for any such New Indications is sold under a trademark or trademarks other than the Trademark(s) (unless prohibited by the FDA or other Regulatory Authority, in which case the Trademark(s) may be used) and is developed and sold in a formulation and dosage strength that does not create a reasonable potential that the Product for such New Indication could be substituted by prescribers, dispensers and/or Third Party payers for any Product being Co-Promoted by the Parties (the "Substitution Product"). For the avoidance of doubt, it is understood that "reasonable potential" may include situations where the Substitution Product is marketed, promoted, distributed or sold for use other than for use in the Initial Indications (or any other indication then being Co-Promoted by the Parties), utilizing a different trademark from the Trademark(s), and where the Substitution Product is labeled for use in indications that are solely outside the field of psychiatric disorders. In furtherance of, but without otherwise limiting Organon's obligations pursuant to this Article 4.6, Organon covenants and agrees that during the Term in each Country in the Territory, Organon shall not, and shall ensure that its Affiliates and licensees shall not, market, promote, distribute or sell any Product for a New Indication in a [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] or [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] formulation with a [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] mg, [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] mg, [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] mg, [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COM...
New Indications. If, from time to time during the term of this --------------- Agreement, ORTHOVITA files with respect to a Product(s) for a dental indication other than the Indications, then ORTHOVITA shall promptly notify 3i in writing of such filing as provided by Section 10.4 below.
New Indications. Company shall have the right, in its sole discretion, to pursue a New Indication for the Product in the Territory (and to engage in development work and clinical trials outside the Territory for such purpose pursuant to the provisions of Section 2(a)), subject to and in accordance with the terms and conditions of this Agreement. If Company decides to pursue any such New Indication, Company shall be solely responsible at its own expense for accomplishing all Product development and commercialization, including without limitation (1) any pre-clinical, clinical and regulatory work, additional clinical testing or other studies and manufacturing requirements relating to the Product for such New Indication; (2) all FDA and other regulatory obligations post approval for such New Indication; and (3) any other Product and medical requirements relating to the sale or marketing of the Product for such New Indication.
New Indications. (a) As provided in the Ex-US Agreement, Protalix shall notify the Steering Committee, at least every six (6) months during the Term, of any material updates with respect to any material Development activities, with respect to the Licensed Product for a New Indication (a “New Use”).
(b) [***]
(c) [***] [***] Redacted pursuant to confidential treatment request.
New Indications. Company shall have the right, in its sole discretion, to conduct development and commercialization of the Product for any New Indication in the Territory, subject to and in accordance with the terms and conditions of this Agreement. If Company decides to pursue any such New Indication, Company shall be solely responsible at its sole cost and expense for accomplishing all Product development and commercialization, including without limitation (1) any pre-clinical, clinical and regulatory work, additional clinical testing or other studies and manufacturing requirements relating to the Product for such New Indication; (2) all FDA and other regulatory obligations post approval for such New Indication; and (3) any other Product and medical requirements relating to the sale or marketing of the Product for such New Indication. Subject to Section 5(f), Company agrees to provide BPA with copies of all correspondence and documents to and from FDA and all notices received from FDA regarding such New Indication and to also provide BPA with regular updates as BPA may reasonably request.
New Indications. The JEC is responsible for approval of the Development of a Licensed Product for any new indications in the Joint Development Territory, including, without limitation, HBV and multiple sclerosis. If either party wishes to Develop a Licensed Product for a new indication, such party shall notify the JDC with information describing the proposed target product profile and development program, and the JDC shall determine whether it wishes to recommend such new indication to the JEC for Development as part of the Joint Development Project. The JEC, in turn, shall determine whether it wishes to approve such new indication for Development and Commercialization pursuant to this Agreement.